Monthly Archives: December 2012

Sleep is a powerful tool for weight management. Getting sufficient sleep—for most of us that means 7-8 hours a night—can help keep your appetite in check, curb cravings, and reduce late-night noshing. The problem is that many of us just aren’t getting that much sleep on a regular basis. And sleep deficiency can make controlling weight much more difficult.

A comprehensive new review of research related to sleep and weight offers some perspective on what we’ve learned about the complicated relationship between the two.

“Partial Sleep Deprivation and Energy Balance in Adults: An Emerging Issue for Consideration by Dietetics Practitioners” is published in the Journal of the Academy of Nutrition and Dietetics.

Researchers examined studies from the past 15 years on the possible influence of partial sleep deprivation and weight control. They emerged with a broad consensus: partial sleep deprivation appears to have a significant impact on weight—how easily it is gained, lost, and maintained. Partial sleep deprivation, in this case, is defined as sleeping fewer than six hours per night. The Centers for Disease Control estimates that nearly one-third of working adults in the U.S. are sleeping no more than 6 hours per night, an indication of just how broadly lack of sleep may be contributing to our culture’s problems with weight.

This review revealed consensus among multiple studies about some of the ways that sleep can influence weight. Partial sleep deprivation disrupts the normal levels of two hormones that are critical to regulating hunger and appetite: ghrelin and leptin. Studies show that even mild and short-term sleep deprivation can result in imbalances to these hormones that govern appetite.

Ghrelin is a fast-acting hormone, produced in cells of the stomach, which spurs appetite and drives us to eat. Ghrelin may particularly increase appetitefor high-calorie foods. There’s evidence that ghrelin may also directfat towards the midsection of the body, where it is most dangerousto health. When the body is deprived of sleep, production of ghrelin increases. Research shows that even a single nightof sleep deprivation can elevate ghrelin levels—and appetite.

Leptin is a hormone that suppresses appetite by communicating to receptors in the brain that the body has the energy it needs to function, and doesn’t need to take on more. Leptin is produced in white fat cells throughout the body. The amount of fat in the body, then, influences the amount of leptin produced. When leptin levels are lower than normal, we’re less likely to feel full after eating. Food also appears more enticing to people with low leptin levels, according to research. Low sleep suppressesleptin production, making us more likely to feel ongoing pangs of hunger. Even short-term sleep deprivation has been shownto reduce leptin levels.

With these hormonal imbalances at work, it’s little surprise that sleep-deprived people are more likely to gain weight and to have difficulty maintaining a healthy weight. More than a third of adults in the US are obese, as are 17 percent of children, accordingto the Centers for Disease Control. Obesity, with its increased risks for many serious health problems—including diabetes, heart disease, stroke, and some types of cancer—is arguably our nation’s leading public health problem. A recent study by the CDC projectsthat half of all adults in the U.S. will be obese by the year 2030. Our collective weight problem endangers millions of lives and costs billions of dollars.

Sleep-disordered breathing, which includes snoring and sleep apnea, isn’t just an adult condition: A new study from Finland shows that as many as one in 10 six-to-eight-year-olds may also have it.

“Craniofacial morphology but not excess body fat is associated with risk of having sleep-disordered breathing—The PANIC Study (a questionnaire-based inquiry in 6–8-year-olds)“ is published in the European Journal of Pediatrics.

The study, which was conducted by researchers from the University of Eastern Finland, included 512 kids from Finland between ages six and eight. The researchers examined their sleep disturbance status, as well as how their top and bottom rows of teeth fit together and their face shape (craniofacial morphology).

Researchers found that being overweight and obese wasn’t linked with sleep-disordered breathing in kids, as it may be with older adults. Rather, craniofacial or dental issues seemed to be at play, according to the study.

“If a child has symptoms of sleep-disordered breathing, his or her craniofacial status and dental occlusion need to be examined,” study researcher Tiina Ikävalko, an orthodontic specialist and a clinical lecturer at the university, said in a statement. “On the other hand, children with tonsillar hypertrophy, crossbite and convex facial profile should be examined to assess the quality of their sleep.”

The prevalence of sleep-disordered breathing in kidsfound in this study is not too different from that previously reported by the American Academy of Otolaryngology-Head and Neck Surgery, which said that snoring is commonplace in about 10 percent of all kids, and obstructive sleep apnea is prevalent in about 2 to 4 percent of kids.

Potential health risks from sleep-disordered breathingin kids include attention problems, bedwetting, increase in insulin resistance, increase in blood pressure, and even a decrease in growth hormone, the American Academy of Otolaryngology-Head and Neck Surgery reported. Since enlarged adenoids and tonsils are a common cause for sleep-disordered breathing in kids, getting these removed could help to treat the condition for some.

Researchers re-analyzed results from more than a dozen clinical trials of the most common type of sleeping tablets, known as Z-drugs (non-benzodiazepine hypnotics).

These drugs are frequently used in the UK and USA as a short-term treatment for insomnia with almost £25m worth of prescriptions handed out in Britain each year. However, some health experts have questioned whether the benefits of Z-drugs justify their side effects, which can include memory loss, fatigue and impaired balance.

Questions have also been raised about the validity of published research into the effects of these drugs based on trials sponsored by pharmaceutical companies themselves.

Academics from the University of Lincoln, Harvard Medical School and University of Connecticut conducted a meta-analysis of data from clinical trials of Z-drugs comparing drug effects with placebo effects. This type of comparison enables researchers to determine how much of the drug effect comes from the constituents of the drug itself, and how much is due to other factors (like the placebo response or regression to the mean).

They used data submitted by pharmaceutical companies to the US Food and Drug Administration (FDA) for approval of new products. This included 13 clinical trials containing 65 different comparisons and more than 4,300 participants.

The FDA collates results from both published and unpublished studies, enabling researchers to avoid common types of bias (such as reporting bias) which can undermine other research based on sponsored trials.

Their findings indicate that once the placebo effect is discounted, the drug effect is of ‘questionable clinical importance’.

Lead author Professor Niroshan Siriwardena, from the School of Health and Social Care at the University of Lincoln, said: “Our analysis showed that Z-drugs did reduce the length of time it took for subjects to fall asleep, both subjectively and as measured in a sleep lab, but around half of the effect of the drug was a placebo response.

“There was not enough evidence from the trials to show other benefits that might be important to people with sleep problems, such as sleep quality or daytime functioning.

“We know from other studies that around a fifth of people experience side effects from sleeping tablets and one in one hundred older people will have a fall, fracture or road traffic accident after using them.

“Psychological treatments for insomnia can work as effectively as sleeping tablets in the short-term and better in the long-term, so we should pay more attention to increasing access to these treatments for patients who might benefit.”

He said future studies of sleeping tablets should investigate a broader range of outcomes, not just time taken to fall asleep, and that pharmaceutical companies should be more transparent in disclosing results from their studies so that researchers can independently analyze their results.

In existence for little more than a year, Somnetics International Inc has managed to make a big impact with a small product. Clarence Johnson, president and CEO of Minneapolis-based Somnetics, is not all that surprised that a .94-pound CPAP unit would cause a stir, but three awards in the span of 12 months exceeded even his lofty expectations.

During that time, the makers of Transcend earned the Medtrade 2011 Innovation Award, the Medtrade Spring 2012 Provider’s Choice award, and the Frost and Sullivan Global Product Differentiation Award in the sleep disorder breathing category. The honors validated what Johnson had deemed an “interesting technology” in 2009. At that time, he organized a group to acquire the intellectual capital that was able to effectively miniaturize CPAPs.

With his own energetic engineers putting on the finishing touches, the company launched the Transcend in October 2011. “People were a little skeptical at first,” remembers Johnson. Specifically, many questioned whether the small company with the small product could compete in a land of giants.

Johnson freely acknowledges the sizable competitors outside his door, but a background as an entrepreneurial veteran has taught him to stay out of the big-boy sand box, at least for now. “We are not going to take away market share from the big players of ResMed, Respironics, and Fisher & Paykel,” he says. “They do an excellent job, and we don’t target them. We are a small company looking to serve patients who enjoy an active lifestyle. These patients see our device as an alternative that allows them to do that.”

Johnson hesitates to call Transcend a “travel device,” even though it can certainly serve that purpose. Instead of shoehorning a travel niche, the Transcend is aimed at those who camp, hunt, fish, climb mountains, or prefer to have a smaller unit at a second home. “Whether it’s a cash sale or a primary therapy sale, it makes no difference,” adds Johnson. “Patients really don’t have a good choice right now other than Transcend, because everything is tied to a bedside and plugged into the wall. If you don’t have power at 10,000 feet when you’re climbing a mountain, you’re out of luck. We have solar battery chargers. We have opportunities for patients to live the life they want to live. That’s our market, and we think that’s a big population of patients.”
Niche “Too Small” for the Big GuysThe 30 employees who hone and market the Transcend and its accessories have gotten behind Johnson’s vision, thanks to an energetic approach that seeks to maximize the advantages of a small company. With fewer employees on the payroll, a smaller market niche can be readily embraced.

“While we expect to expand over the next 12 to 18 months, it’s true that we can carve out smaller parts of the market—parts that are too small for the others to really go after,” explains Johnson. “The big companies have a number of products, but it’s difficult for them to market effectively into a small niche. It’s easy for us to do that. We can capture small niches of the market that to us are big, but to them are too small. We can grow a sizeable company doing that. This is a big market, and we don’t need a huge piece of the pie to be successful.”

Most pieces of the pie have come courtesy of cash sales, an ingredient of the sleep business that has increased its viability thanks to the Transcend. The Transcend has been almost exclusively a cash sale item, largely because it does not have a traditional humidifier. As a result, DMEs and sleep labs have been hesitant to offer it to patients as a primary therapy device.

As an alternative to traditional methods, Transcend offers Waterless Humidification,™ a heat moisture exchange technology that has long been used in hospital respiratory care. The patent-pending design works naturally with a patient’s breathing to provide needed humidification, but Johnson acknowledges that further education is needed for the system to acquire wide acceptance in the primary care realm.

Transcend’s “game plan program” supplies free marketing materials to DME partners and sleep labs to spread this education. “We have a call center that gives advice on how to use the ‘game plan,’” says Johnson. “We work with them as a coach to enhance sales. That has been effective in ramping cash sales with DMEs and sleep labs. There can be a paradigm shift away from only reimbursement-driven CPAP to cash sales outside of the Internet—where we sell a lot of units as well. The cash sale market is mostly for patients who are already on CPAP and are looking for an alternative to travel with, a CPAP for a second home, or an option that allows for uninterrupted power such as with our battery.”

Global Reach, Long Term StrategySomnetics International Inc is owned by investors who share a long term strategy that extends well beyond American borders. Transcend already has a global distribution network, and Johnson intends to expand that significantly in 2013.

“We are selling our devices now pretty much around the world, and we’ll continue to add products to our line,” muses Johnson. “We do not have a short-term goal of growing the technology and selling the company, or anything like that. It is our intention to make Somnetics a viable operating company, in this market space, for the long term.”

Is Transcend a Carry On?As a medical device, Transcend does not count as a carry-on item on airplane flights. Somnetics and others advise patients to never check a sleep apnea therapy device with baggage because it can be damaged through normal luggage handling procedures. Sleep labs and sleep physicians can provide patients with a letter stating the diagnosis and the need to carry the device. Advise patients to call the airline in advance to clarify procedures and in-flight policies.

ResMed Inc., one of San Diego’s largest medical device companies, is evaluating whether it should move its headquarters outside of California.

ResMed CEO Peter C. Farrell cited California’s tax increases, strengthening union presence, strict regulations and the Democratic majority in the state Legislature as reasons the company is looking elsewhere. The company posted revenue of more than $1 billion last year.

“We’re trying to evaluate whether or not it’s the best thing for our shareholders — and for our future — to remain headquartered in California,” Farrell said. “California just doesn’t have a business-friendly environment, and my gut says it will get worse. Do we want to sit around on the deck of the Titanic?”

A board-appointed task force is looking at Texas, South Carolina, Singapore and Ireland as potential future hubs for the company. Farrell said the committee will present its findings at ResMed’s next board meeting in February.

The company, founded in 1989 in Australia and headquartered in San Diego since 1990, is a world leader in manufacturing devices that assist patients suffering from sleep apnea. It employs about 400 in California, and 3,700 worldwide. In 2009, ResMed spent about $120 million to build its new, 250,000-square-foot headquarters in San Diego.

“Of course, it would be very disruptive to employees to move everything,” he said. “We’re not going to pull the trigger without properly thinking it through.”

For medical interns working extended-duty overnight shifts, a protected sleep period of 5 hours is feasible and can increase time slept by interns and alertness the following morning, according to 2 randomized controlled trials conducted in parallel at 2 Philadelphia hospitals.

The protected sleep intervention led to an increase in the average amount of time slept of about 50% from 2 hours to 3 hours, a reduction in the proportion of interns who didn’t sleep at all overnight from about 18% to about 6%, a 50% reduction in the proportion with disturbed sleep, and improvements in cognitive function postcall.

“To the extent that protected sleep periods are feasible and improve alertness, they may provide a reasonable alternative to mandated shorter shifts,” the authors say.

“Effect of a Protected Sleep Period on Hours Slept During Extended Overnight In-hospital Duty Hours Among Medical Interns” is published in JAMA.

The protected sleep period concept has not been widely implemented “because up until now it was not thought to be feasible,” first author Kevin Volpp, MD, PhD, staff physician, Philadelphia Veterans Affairs (VA) Medical Center and professor, medicine and health care management, Perelman School of Medicine and the Wharton School, University of Pennsylvania, Philadelphia, told Medscape Medical News.

“Previous efforts to do this,” he explained, “had resulted in low adherence rates.” In a University of Chicago study published in 2006, the rate was only 22%. “We achieved 98% adherence rates by making protected sleep periods part of the standard intern schedule,” Dr. Volpp said.

“There are not enough studies in the medical literature on early cardiovascular dysfunction in patients with [obstructive sleep apnea], when active steps can be taken to prevent progression to heart failure,” study author Dr. Raluca Mincu of Bucharest, Romania, said in a European Society of Cardiology news release.

Because obstructive sleep apnea leads to many cardiovascular disorders, the researchers compared early cardiovascular dysfunction in sleep apnea patients and patients with diabetes, which is a typical risk factor for cardiovascular disease, Mincu added.

The study included 20 patients with moderate to severe obstructive sleep apnea, 20 patients with treated type 2 diabetes and 20 healthy people. They underwent tests to assess the condition of their arteries.

“Patients with moderate to severe [obstructive sleep apnea] had endothelial dysfunction and higher arterial stiffness than [the healthy people], and their results were similar to patients with diabetes,” Mincu said. This suggests that obstructive sleep apnea is associated with a high risk for cardiovascular disease, Mincu added.

Endothelial dysfunction means that the inner lining of blood vessels does not function normally.

“Patients should realize that behind snoring there can be a serious cardiac pathology and they should get referred to a sleep specialist,” Mincu said. “If they are diagnosed with obstructive sleep apnea, they are at increased risk of cardiovascular disease and need to adopt a heart-healthy lifestyle to reduce that risk.”

“Our study is a signal for cardiologists, pneumologists and general practitioners to work together to actively diagnose obstructive sleep apnea, administer the appropriate treatment (continuous positive airway pressure — CPAP) and assess arterial function,” Mincu concluded. “This will help avoid progression of early cardiovascular dysfunction through to heart failure, the final stage of heart disease.”

Researchers found drugs including diazepam and temazepam were linked with a higher risk of developing the lung infection and further studies on their safety was needed.

Patients who were taking the drugs were also more likely to die from pneumonia if they contracted it, it was found.

Around one in ten elderly people are thought to have taken the drugs.

The class of drugs known as benzodiazepines have ‘significant immune effects’ the researchers said and previous concerns raised about patients on intensive care units has led to a reduction of their use in those critically ill people.

Experts said the deep sleep induced by the drugs may mean that secretions can build up in the lungs.

In the study just under 5000 patients who had been diagnosed with pneumonia between 2001 and 2002 were each compared with six similar people, matched for age and sex, and drawn from the same GP practice, who had not been diagnosed with pneumonia.

Having ever taken a benzodiazepine was associated with a 54 percent increased risk of pneumonia and those who did contract it were one fifth more likely to die within a month and a third more likely to die within three years.

The findings showed that current users of the drugs were 90 percent more likely to have contracted pneumonia, recent users who had been prescribed them between one and three months ago were 95 percent more likely to have the infection and past users were 40 percent more likely.

The drugs were also evaluated individually and diazepam, lorazepam and temazepam, but not chlordiazepoxide were associated with an increased risk of pneumonia along with a non-benzodiazepine called zopiclone.

Lead author Eneanya Obiora, of Nottingham University, wrote in the journal: “Benzodiazepines and zopiclone are commonly prescribed medications that have significant immune effects.

“Our data herein suggest that they may increase both the risk of and mortality from pneumonia.

“This is consistent with data from clinical trials and concerns expressed over the intensive care unit effects of these drugs leading to movement away from benzodiazepine sedation.

“Nonetheless, given the widespread use of benzodiazepine drugs, further studies are required to evaluate their safety in the context of infection.”

Benzodiazepines have a wide range of uses and are commonly prescribed for anxiety, epilepsy, muscle spasm, and insomnia. They are also frequently used in palliative care, as a sedative, and to help those with an alcohol problem to “dry out.”

Prof. Donald Singer, member of the British Pharmacological Society and Professor of Clinical Pharmacology at the University of Warwick, said: “This report suggests the need for caution, particularly in the longer term use of benzodiazepines.

“However the authors note that they cannot be sure whether their findings are cause and effect or have other explanations.

“For example, it was puzzling that risks from these drugs appeared lower in patients with more complex disease burden.

“There are also risks to stopping these medicines suddenly so patients with concerns should seek advice from their doctor or pharmacist.”

Prof. Peter Openshaw, Director of the Centre for Respiratory Infection, at Imperial College London, said: “We normally tell patients with chronic bronchitis that they should avoid using sleeping pills since these may cause respiratory suppression and inhibit coughing.”

“The normal reflexes that help to clear secretions from the lungs at night may be inhibited.”

“It seems likely that the effects described in this study are due to deep sleep caused by the drugs.”

“This causes secretions being retained in the lungs, so that bacteria are not cleared so fast and cause infection.”

“This seems more probable than the possible effects of the drugs on the immune system, which may or may not be important. It is also possible that those needing sleeping pills are more prone to pneumonia for other reasons, and that the link is not causal.”

“Whatever the explanation, it’s an interesting paper and important finding.”

Dr. Jodi Lindsay, Reader in Microbial Pathogenesis, at St George’s, University Of London, said: “The study shows an unexpected and intriguing association between benzodiazepines and pneumonia.

“The next step will be to understand why. This could lead to safer anxiety and sedative drugs as well as improving strategies for preventing and treating infections.”

Around two percent of the population in the UK and the USA have taken benzodiazepines for 12 months or more, and among the elderly this prevalence rises to one in 10.

The pneumonia cases were more likely to have had pneumonia before, to have had other serious illness, including a heart attack, depression, and psychotic illness; underlying illnesses; and to be current smokers than those in the comparison group but these factors were taken into account and did not change the findings.

Sleep Scholar for Sleep Medicine Professionals

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Ahrens A, McGrath C, Hägg U. Source Discipline of Dental Public Health. Abstract Oral appliances (OAs) are increasingly advocated as a treatment option for obstructive sleep apnoea (OSA). However, it is unclear how their different design features influence treatment efficacy. The aim of this research was to systematically review the evidence on the efficacy of different OAs […]

The Salter Labs BiNAPS and other select pressure transducers are utilized during sleep disorder studies to simultaneously measure respiratory airflow and snore pressure signals via a sleep diagnostic cannula. When titration to CPAP is initiated it previously required switching to a snore microphone/sensor. Now with the Salter Labs® SnoreTac™ Snore Sensing Adapter, all that is required is […]

Sleep Disorders have dominated the health and wellness blogs and news sites for the last several years. It is time for patients and caregivers to wake up to the issues that come from sleep apnea. More than 40% of adults in the U.S. have a disorder such as snoring, insomnia, restless leg syndrome or sleep … Continue reading Sleep Apnea Therapy: Its all about the TEAM!→